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.ascastany gg Davis Taylor Heltemes Kerr SP MEMORANDUM FOR:
Victor Stello,._Jr.
Murray Executive Director for Operations-Shelton Lesar William C.-Parler, General Counsel McGuire FROM:
l'J. Chilk, Secretary
SUBJECT:
STAFF REQUIREMENTS - AFFIRMATION / DISCUSSION AND VOTE, 3:30 P.M., THURSD.TY,. JANUARY 29, 1987, COMMISSIONERS' CONFERENCE ROOM, D.C.
OFFICE (OPEN TO PUBLIC ATTENDANCE) l I.-
SECY-97 Recuest for Stay of Immediate Effectiveness Provision of '.jcense Suspension Order by Advanced Medical Systems, Inc.
The Commission, by-a 5-0* vote, approved an order with'modifica-tions by Commissioner Carr which disposes of a request by Advanced Medical Systems, Inc. for a stay of the immediate effectiveness provision of the license suspension order issued by_the Director, IE, by referring the request to the administra-tive law judge hearing the merits of the licensee's complaint.
(Subsequently, on January 30, 1987 the Secretary signed the order.)
Section 201 of the Energy Reorganization Act, 47 U.S.C.
- S5841, 1
provides that action of the Commission shall be determined by a
" majority, vote of the members present." : Commissioner Asselstine was not present whu. this item was affirmed.
Accordingly, the formal vote of the Commission was 4-0 in-favor of the decision.
Commissioner Asseletine, however, had previously indicated that he vould. approve this paper anC-had he been present he would have affirmed his prior vote.
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'8ECY-86-366 - Final Rule on Licenses and-Radiation Safety-s y
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- p Requirements for'Well Loqqing (New Part 39y 4p.
The) Commission,Eby.a 5-0* vote, approved a final order on f
-specific radiationLsafety requirements related to the use olicensed~
the very important role of training for worker Because-of1 1.
safety in well logging, priority should be-given to-the development of the training manual for well loggers which The manual should is scheduled for. publication _mid-1987.
i to serve ac
.be prepared using clear text and illustrat ons a< ready reference on radiation safety issues for well h
- leggers similar to the training manual prepared for industrial.radiographers (NUREG/BR-0024).
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Requirements'for calibration of radiation survey instruments. g 2.
to an accuracy of-+20 percent in 39.33 are inconsistent with accuracy requTrements in proposed Regulatory Guide
['l,g,a#y' Although OP-032-5 and other. Division 8 Regulatory Guides.the Commission it believes that calibration as it applies to well logging, requirements for radiation-survey instrumentation should be consistent in NRC regulations and guidance unless exceptions are defined for specific applications.
i the staff notes that NRC
~lb In-response to a public comment, regulations do not contain criteria for acceptable levels
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of residual contamination in soils.
A 1986,-on the subject rulemaking observes that this The Commission is aware f.h /J*
a 29, involves afbroader agency problem.
that the staff is participating in an interagency task p/'
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force headed by EPA to define limits of release for unre-
,j It is also aware -of other NRC initiatives to.j;-
stricted use.
As define de minimus and levels below recul-tory concern.~he EDO advise it-l a broader issue the Commission c.8ks
- nd will result in-l as to how these activities are relat#:
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ionsistent release limits for all NRC ' censed activities.
IE This rulemaking should not be held up for this response as it involves a broader agency issue.
(RES) (DUE DATE: 10/87) 4 a
O w-42 U.S.C. 55841, Section 201 of the Energy Peorganization Act,
-ined by a provides that action of the Commission shall be detr Ce ission r 'sselstine
-" majority vote of the members-present."
Accort..9 y, the 1
was not present when this iten. was affirmes formal vote of the' Commission wos 4-0 in fassr of the decision.
Commissioner Asselstine, however, had previously indicated that he-would approve this paper and had he been present he would have affirmed his prior vote.
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ADVISORY COMMITTEE ON RE ACTOR SAFEGUARDS -
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The Honorable Lando W.'Zech, Jr.
Chairman t.S. Nuclear Regulatory Comission Washington, D.C. 20555-
Dear Chairman Zech:
SUBJECT:
ACRS COMMENTS ON THE DEVELOPMENT OF RADIATION PROTECTION
-STANDARDS-During, the 331st meeting of ' the Advisory Committee on Reactor Sefe-Office of
- guards, November 5-7, 1987,. we met with Floyd L. Galpin,(EPA),
Environmental Frotection Agency and l*
Radiation Programs, U.S.
Robert.E. Alexander, Office of Nuclear Regulatory.Research, U.S. Nuclear Regulatory Comission (NRC), to discuss current developments related to radiation, protection standards.
These discussions included reports on the efforts of (1) EPA to establish individual dose rates for members of l
the public that would be considered.to be "below' regulatory concern" lj L
-(BRC), and.(2) an interagency comittee, coordinated by EPA with NRC l-support, that is engaged in developing guidance for federal agencies on radiation protection of the pblic. These-topics were also subjects of discussion by nur Waste Management Subcomittee during its meeting on-October 15-16, 1987.
Current. EPA efforts are being directed primarily to developing limits on-dose rates ' from low-level radioactive wastes, including: the development-of dose rates that are BRC,. for members of the public. 'Several proposals on this topic from outside organizations have been reviewed
. As such, this work
-and endorsed by the EPA's Science Advisory Board.
holds promise for alleviating some of the problems-being encountered in the management and disposal of such wastes.
Although these-efforts have revealed inconsistencies in existing radi-ation p)rotection standards (which will require considerable effor resolve, and althoingh problems remain (such as clarifying dis'tinctions in dose rates considered to be BRC' and those considered to be de mini-J
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mis), we are very encouraged by these activities.
They hold Pomise, not: only of providing a coherent system of radiation protection stand-ards, but also of placing the risks from low radiation dose rates in better perspective.
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November 10,!1987 ki Thel Honorable. Lando k - Zech,- Jr i - 2. - -
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For these reasons,.we recomend that the' NRC continue its' oupport of and lend - encouragement' to the. work of the interagency comittee and the related efforts of the EPA.
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Sincerely,,
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William Kerr H
Chairman' 3-l L
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April 22, 1988 Taylor i (, ' "
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. sacnETAny Murley, NRR Murray, OGC SNeuder, RES p,_RES MEMORANDUM FOR Victor Stello, Jr.
Executive Director for O ations l7 ROM : '
Samuel J. Chilk, Secreta, C)
SUBJECT:
STAFF REQUIREMENTS - BRI EF; ;NG ON THE STATUS OF EFFORTS TO CTVELOP A DE hT4IMIS POLICY, 2:00 P.M., MONDAY, MARCH 14, 1988, COMMISSIONERS'
- CONFERENCE ROOM, D.C. OFFICE (OPEN TO PUBLIC
-ATTENDANCE) i
- The Commission has reconsidered.the suspense date of September l<
i 9, 1988,.for the staff's options paper on the de minimis policy requested in our previous SRM on the same subject (copy attached).
The staff is requested to submit by August 1, 1988, the options T
paper on a de minimis policy.
This will assure the Commission l
' reasonable time to review the proposed policy paper prior to the staff meeting with' international groups on this subject.
i teme-) - (RES)
(SECY Suspense 8/1/88) 1 l
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-Attachment l
>As stated cc Chairman Zech
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' Commissioner Roberta Commissioner Bernthal Commissioner Carr-Commissioner Rogers OGC
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March.30, 1988 I%,-o...,* /
cmCs of THE.
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Victor Stello, Jr. Executive Director for O(c MEMORANDUM FOR:
d ations Samuel J. Chilk, Secreta FROM:
STAFF REQUIREMENTS - BRIEFqiG ON THE STATUS OF EFFORTS TO DEVELOP A DE (IFINIG' POLICY, 2:00 4
SUBJECT:
14, 1988, COMMISSIONERS' P.M.,
MONDAY, MARCH CONFERENCE ROOM, D.C. OFFICE (OPEN TO PUBLIC
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ATTENDANCE)
The Commission was briefed by the staff on the status of t
nt-identifying a efforts to develop a Commission policy sta emelevel of radia h
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'lation would be limited or unwarranted.
The Commission requested and the r.caff agreed to below establishes-a generic number for' exposures that areThe paper shou in our data base regarding radiation risk and shou regulatory concern.
l Consideration should be given to the assumptions made in establishing de facto BRC levels-that appear in current NRC The staff should also discuss the approach for implementing such a number for multiple sources or licensed regulations.
activities.which doet not require justification by individual licensees.
This options paper is to be acted upon by the Commission prior to the' staff. meeting with international groups 9/9/88) on this subject.
'(SECY Euspense (EDO)
Commissioner Bernthal requested the staff to provide him the bases. and analytical techniques used by other agencies (e.g.,
in developing a de minimis policy / regulation on toxic waste (e.g., did they use a-linear hypothesis?).
EPA and FDA)
(SECY Suspense 4/29/88)
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Subrequent to the meeting, Commissioners Roberts and Bernthal 1
requested that the~ staff's options paper should explicitly
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identify the undergirding assumptions and projected risk estimates, both societal:and individual, used in the establish-Specific
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- ment of.such BRC limits appearing in NRC regulations.
points staff should address include:
In 1981, the Commission revised Part 20 to permit disposal ofscintillationcocktai}4and agimal carcasses containing trace concentrations of C or H without regnd for their radioactivity.
Also,' specified curie amounts of both L
isotcpes may be released annually into the sewerage Some regulatory control remains (e.g. record-system.
keeping and limitation on_use of contaminated carcasses) but in effect, once released to the environment NRC exerts no further control, thereby setting a floor to ALARA for What calcu-(
these specific isotopes and applications.
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lations of societal and/or individual risk were employed Were the in determination of these exempted levels?
models and assumptions the same as those used to arrive at tables of exempt quantities elsewhere in NRC regs?
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Staff raises the question on page 4 of SECY-83-69 as to whether a definition of " radioactive" can be-usefully established.
Not mentioned in Enclosure 2 is the fact that DOT regulations do precisely that (49 CFR 173.403).
For purposes of transportation, a radioactive material is defined as a material having a specific activity of 2 l
This definition is incorporated in NRC nCi/g or greater.
not as a definition per se, but regulations (10 CFR 71.10)
.as an exempt quantity under NRC transportation regulations.
Given that a What is the origin of this 2 nCi/g limit?
limit on total specific activity limit applies to any and all isotopes what assumptions were made regarding chemical form, pathways to the environment, critical organs, etc.?
For purposes of enforcing the many de facto BRC limits which exist in NRC regulation what explicit allowance is (Recall, made for instrument and measurement uncertainties?
that the commission only just recently promulgated require-ments for some measure of QA for dosimetry processors.)
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Accartable levels of residual surface contamination are Facilities with surface designed in Reg. Cuide 1.86. contamination levels below those specifie for unrestricted use.
How many and what types of licensee facilities have been decommissioned using these criteria?
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Ny The Commission'was recently made: aware of some"of the 3M static eliminator.
Lhistory behind the licensing-of:
'defices.-. The general: license.for.these: devices' allowed up
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to 5'nci'of. removal' activity without any action being.
Do similar required on the part:of-the general licensees.
l provisions exist.in other licenses? :What is the origin of What= assumptions of
- the 5 nci allowable leakage rate?
t risk,were made.to justify ~this number 7 Chairman Sech cc
. Commissioner Roberts Commissioner.Bernthal.
Commissioner.~Carr Commissioner Rogers.
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h t.(4'.y May 6, 1988 MEMORANDUM FOR:
D. W. Moeller i
M.J.Steindle$dk FROM:
SUBJECT:
DECISION MAKING FOR "BELOW REGULATORY CONCERN" The meeting of the Waste Management Subcomittee on May 4,1988 on the subject topic uncovered, somewhat as expected, a tangle of issues, existing numerical. values, past practices, and uncertain basic data about Below Regulatory Concern -(BRC).
It may well be that the indi-vidual Comissioners have not had the time to study in-depth this convoluted topic.
It might be noted, however, that the question posed by them-and reflected in SECY 86-69, tne transcript of the briefings by the staff, and the questions posed by Comissioner Bernthal-are all I.
pointedly directed at important aspects of the BRC controversy.- Fur-ther, the basic decision identifying a policy base for the NRC may well be made on non-technical considerations, but the need to identify conse-quences of such decisions falls on the technical comunity.
If the Comission desires to participate in the October international meeting on BRC and there put forth a thoughtfully developed U.S. posi-tion, we as advisors should aim to provide them with ' a communication
-that, together with the transcript of the subcomittee meeting, could clarify the issue.
In that connection, it may be that the 'ollowing could be of use:
I.
Some basic principles for evaluating BRC levels.
I believe that there were a number of basic principles enunciated in masked fashion during our meeting. Some appear mutually contra-dictory and very likely no two or more could be applied simulta-neously. These include:
A.
If an analysis shows that, for a given level (concentration).
of radioactive material, regulation of that material will not reduce the risk from it, then that level is BRC; n
3.
If regulation requires expenditure of. more than $1000 per p man-rem avoided, that level is BRC; C.
If the risk from a source is comparable to that from natural background (or some fraction thereof), that source level is BRC; ENCLOSURE 2 1
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If the risk from a source cannot be experimentally measured, then that source is BRC; o
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If the risk from a source is less than that from known sources now not regulated, then the snurce is BRC; F.
If the risk from a source is equivalent to the reactor safety goal, currently believed to be in the range of 12 - 20 mrem /y, then that source is BRC; G.
If the risk from a source is 0.1% of other risks accepted in-
-society, then the source is BRC; H.
If the' risk from a source is calculated to be less than the.
risk used by other agencies to define their BRC, then the '
source -is BRC for' the Nuclear Regulatory Comission; If a source is arbitrarily determined to represent a low risk, declare this to be BRC but agree to examine the evidence periodically to evaluate the need for modification of the BRC
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If A1. ARA-practices no longer yield a reduction in risk, that L\\
level is BRC.
Clearly, each one of these " principles" can be applied to scenarios that will yield a number, generally a source strength, that can be translated' into an absorbed whole body equivalent dose and a risk level.
This listing. contains " principles" that-would likely not be acceptable by a society that does not treat relative risks on a rational basis, i.e.
L risks from some sources are more acceptable than the same risk from other sources.
II. Average:value of the BRC risk It seems likely that some of the items I. A-J are unsuited for further. consideration based on the likely magnitude -of ~ the con-tained risk. Eliminatingthese(e.g.,I.G.,I.D.)~ reduces'thelist of potentially applicable bases for setting the BRC to those whose calculated values may fall into a relatively narrow range.
I believe this range could be defined and may well be close to the 1-10 mrem /y that was mentioned as seetaing reasonable on'the basis of what we heard.
While the process of " expert opinion" is acceptable in some quarters, the Comission may require something different.
It may be useful, therefore, to urge the staff to provide numerical values for the estimated risk based on the i
selected " principles" noted in Section I.
III. Conclusion I believe we can conclude and transmit to the Comission two coments pertinent to'the BRC matter before it.
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The-levels of BRC-in terms of curies or curies per unit mass, i.e., a measurable value, no matter how derived, should use individual-health risk (cancer deaths) as its basis.
B.
While it is-difficult to ratior'lize a narrow (single) basis.
for determination of the risk that-is derived from sources that are BRC,-it appears that there is a good chance that an.
acceptable risk will result from a BRC scurce that yields 'an' annual; effective dose equivalent in the neighborhood of 10 mrem.
Therefore, if ~ nany pertinent " principles" result in-this value, thistwould point to the rationalization of such a risk.
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Raymond Fraley, Executive Director Advisory Committee on Reactor Safeguards FROM:
Victor Stello, Jr.
Executive Director for Operations
SUBJECT:
.ACRS SUBCOMMITTEE REPORT ON "BELOW REGULATORY CONCERN" AND "DE MINIMIS" CONCEPTS Your letter of May 11, 1988 transmitted the ACRS Subcommittee on Waste
= Management's May 5, 1988 report on the above subject'; Given its substance ar.d pertinence, the staff has immediately reviewed the report and submits the following comments for the ACRS's consideration.
The staff has found the Committee's report to be based on a sound understanding of the complexity of the task involved in establishing a BRC level (s).
The
. value judgments under consideration are subject to wide, and likely valid, interpretations which must be made in light of a body of similar judgments made at other U.S. regulatory agencies and by international regulatory groups.
The following comments address the Subcommittee's report on a sequential basis -
.beginning with the responses to questions in SECY-88-69 and carrying through to the comments of M. Steindler.
Issue No. 1:
Efficacy of gener"_vs source specific BRC levels.
The Subcommittee strongly recommended addressing this matter on a generic basis and listed three advantages to this approach:
(1) the desire to set down basic criteria and approaches, (2) the formulation of a consistent point of departure 1'
for individual " source" or " practice" determinations and (3) the avoidance of individual BRC rulemakings for each source or practice.
The staff agrees with these advantages but points out that their value is strongly dependent on how BRC levels are characterized (i.e.,-issue 2). The staff believes, and the Subcommittee appears to agree in response'to issue 4, that an appropriate BRC level for a range of classes of sources and practices requires the application of optimization evaluations (i.e., cost vs Yisk reduction analysis).
Such analysis involves consideration of collective (population) dose which the staff believes can vary fro.m one class of practice to another.
The staf f is pursuing a " generic" approach which includes a three-tiered graded-approach to individual BRC dose and consideration of
,approp'riate population doses.
With this definition of " generic basis," the advantages listed by the Subcommittee can be achieved.
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Expression of BRC levels.
The Subcommittee believed that the BRC level should be expressed.in terms of health risk to an individual and listed several advantages to this approach:
(1)-comparable treatment of all sources and practices, (2) comparability to "BRC"-levels for other toxic substances and (3) avoidance of changes in BRC levels as a result of potential changes in the quantitative relationship between radiation dose and esiculated health effects.
The staff recognizes the validity of all the stated advantages but is trying to avail itself of advantages 1 and 2 through the previously described graded indhidual dose approach to BRC determinations. With regard to the comparability advantage, it should be noted that regulatory decisions applicable to toxic chemicals appear to reflect consideration of collective (population) risk.
The staff believes the rationale in these " toxic chemical decisions" has merit and has attempted to factor in population dose in its proposed BRC policy.
Advantage 3 may appear real; however, if risk coefficients change significantly, the "measurables" actually used to establish and verify an activity would have to be changed irrespective of whether the BRC values were expressed in terms of dose or risk.
Furthermore, by falling back to a risk policy, the NRC would be further separating the policy from the practical "measurables" which eventually must be defined.
The-staff is aware of potential changes being considered by the ICRP but does not foresee the
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likelihood of further significant (order of magnitude) changes in the commonly assigned relationship between dose and risk at low dose levels.
Issue No. 3:
Definition of " sources" and " practices" The staff is-in agreement with the Subcommittee's recommendations.
Issue No. 4:
Definition of cost averted / risk ratios
.or optimization evaluations in the initial The Subcommittee foresaw a neeri efforts to establish an approp'iate BRC level for a range of classes of sources Once the BRC lavel is established, the Subcommittee saw no need and practices.
for such evaluations directed at specific sources or practices for which The staff supports the calculated risks fell below th' established BRC level.
view that once BRC level (s) are established, a cutoff for optimization However, the reason for pursuing a BRC policy evaluations is defined.
involving a three-tiered, graded-approach to individual dose for specific
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classes of practices-is to envelop a range of existing practices (i.e., ranging from exempt consumer products to license terminations involving U-Th The staff believes that the exemptions applied to these contaminated sites).
decisions have been justified on "as-low-as-reasonably-achievable" arguments.
The single BRC risk value alternative would appear to necessitate the need for a number of potential exceptions to the general (generic) level because the optimum level for some practices could be significantly different from the general case.
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Appropriateness of-the linear non-threshold hypothesis.
-This is a very controversial issue.
The staff has varied opinions on this issue with a majority supporting the Subcommittee's view that no other approach is. demonstrably superior.
Issue No. 6:
Definition of "de minimis" risk The staff agrees that NRC should concentrate its efforts on establishment of BRC levels.
However, the staff is considering use of a cutoff level on individual dose below which such doses would not be summed in collective dose evaluations.
The basis for this determination could include a "de minimis" population dose argument.
Staff Response to Additional Comments The staff has been pondering wh' ether the issue involved here is "how safe is safe enough" relative _to high consequence. rare events or "how clean (risk free) is clean (risk free) enough" relative to expected practices.
The latter is the question often asked in the literature relevant to cleanup of toxic wastes.
Some view the safety ggal for latent cancer fatality risk at nuclear power reactors (i.e. 2 x 10 latent cancer fatalities per reactor, year) as being a ceiling on risk of exposure rather than a floor on tolerable risk. This issue
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remains open to be further specified when related to expected BRC practices (which exclude high consequence rare events).
Consideration.of all current' practices would appear to confirm the Subcommittee's view that an appropriate BRC limit on individual dose would assure acceptable collective doses.
However, the staff concern in this area is with potentially widely distributed consumer products, exempted from regulatory l
control under an individual risk (dose) BRC policy without a guideline on population dose.
An alternative, which the staff may consider, would be to include in the policy a provision that the need to assess potential population doses associated with any new " exempted" practice be made on an ad hoc basis..
On the subject of BRC comparisons, health risks have been calculated and comparison to ambient (outdoor) natural background radiation can be made as suggested.
The staff also agrees that evaluation and validation of " pathway" models under a range of individual exposure scenarios is extremely important and that uncertainties must be considered.. BRC determinations which include consideration of a radionuclide's half-life would seem to be necessary and can be-factored into a policy which considers collective (population) dose.
The Subcommittee's C 6 u-- d comments on future BRC policy reexaminations are valid and the staffga Commission commitment on this subject.
Finally, the staff could also support a 10 6 per year fatal cancer risk as a suitable goal for most BRC practices.
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V Staff Responses to M. Steindler Memorandum The staff is in full agreement with the goal to develop a thoughtfully developed U.S. position (possibly an options paper) for presentation at the international workshop in October.
The staff contemplates using most of the applicable principles defined by M. Steindler.
Principle I.D., as Mr. Steindler indicates, would most likely not be considered a cogent argument, although some variation of 1.G. might be used.
As stated previously, the staff is unsure of the applicability of principle I.F.
- Finally, as stated previously, the staff believes that an individual dose on the order of 10 mrem per year (s 2 x 10 8 annual latent cancer fatality risk) could be suitable as a basis for some BRC determinations.
However, the staff is strongly considering the desirability of including, within the BRC policy, provisions through which both higher and lower individual dose goals may be justified.
The. staff is appreciative of the forum presented to discuss the BRC issue with L
the Subcommittee.
The staff's comments in this memorandum have been submitted l
with the intent of developing an effective and reasonable Commission policy, l
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ictor Stello, Jr.
Executive Director for Operations l
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